Experiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case study.

BACKGROUND

Patient and public involvement (PPI) is increasingly recognized as important, yet no guidance exists on integrating young people and family caregiver perspectives in the development of research reporting guidelines. We developed two paediatric-specific extensions with young people (ages 10-24 years) and family caregivers (YPFC) for the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines: SPIRIT-Children and Adolescents 2025 (SPIRIT-C) and CONSORT-Children and Adolescents 2025 (CONSORT-C). This case study describes how we involved YPFC in the development of SPIRIT-C and CONSORT-C and identified enablers of impactful PPI.

MAIN TEXT

We formed a Youth Advisory Group (ages 13-19 years) and a Family Caregiver Advisory Group. A miniseries of two Young Person Reporting Guideline workshops aimed at generating randomised controlled trials (RCT) reporting items were conducted virtually in Canada, England, France, Scotland, and Spain, engaging 42 young people (ages 10-21 years). Young people (ages 19-24 years) and family caregivers participated as panellists in an international Delphi study. Family caregiver advisors actively contributed to the Consensus Meeting and to the writing process of the guidelines' Explanation and Elaboration (E&E) documents. After each project stage, YPFC feedback was collected. PPI impact was defined as tangible changes, learnings, and outcomes, both positive and negative, to the guideline development process and the final guidelines resulting from YPFC co-development. YPFC found their involvement in the project a valuable experience. Their contributions to key project stages, such as the Delphi study, Consensus Meeting, and the development of the E&E documents impacted the final guidelines and E&E documents, with the inclusion of four new youth generated reporting items. Feedback throughout the project informed six "enablers" for productive partnerships in reporting guideline development: (1) designated point person, (2) tailored training, (3) access to project materials, (4) clear expectations on time commitment and compensation, (5) structured check-in sessions, and (6) demonstrated openness to feedback.

CONCLUSION

With careful preparation, investing in impactful PPI enablers, YPFC can meaningfully contribute to the development of research reporting guidelines, improve final deliverables, and ultimately shape research that reflects their perspectives.